DBV712 250 mcg for Peanut Allergy

DBV Investigative Site, Los Angeles, CA
Peanut AllergyDBV712 - Drug
4 - 7
All Sexes
What conditions do you have?

Study Summary

This trial tests if a daily dose of a drug can help children with peanut allergies become less sensitive to it over a year.

Eligible Conditions
  • Peanut Allergy

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Screening up to Month 14

At Month 12
Cumulative Reactive Dose (CRD) of Peanut Protein
Eliciting Dose (ED) of Peanut Protein
Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12
Percentage of Treatment Responders in the DBV712 Group Compared to Placebo Group
Month 12
Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
Month 13
Number of Participants With Systemic Allergic Reactions
Total Score for Scoring Atopic Dermatitis (SCORAD)
Month 14
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

DBV712 250 mcg
1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

600 Total Participants · 2 Treatment Groups

Primary Treatment: DBV712 250 mcg · Has Placebo Group · Phase 3

DBV712 250 mcg
Experimental Group · 1 Intervention: DBV712 · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: screening up to month 14

Who is running the clinical trial?

DBV TechnologiesLead Sponsor
16 Previous Clinical Trials
2,922 Total Patients Enrolled

Eligibility Criteria

Age 4 - 7 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
What site did they apply to?
DBV Investigative Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Is enrollment being opened to individuals below the age of 45 for this experiment?

"This research is open to children aged between 4 and 7 years of age." - Anonymous Online Contributor

Unverified Answer

Does DBV712 250 mcg present any health risks to individuals?

"DBV712 250 mcg has been clinically evaluated for safety, and thus received a rating of 3. This signifies that the drug is in its third phase of testing with supporting evidence from previous trials to back up efficacy and side effect prevention or management." - Anonymous Online Contributor

Unverified Answer

To what extent is the capacity of this medical research limited?

"Indeed, the published information on clinicaltrials.gov attests that this research is actively enrolling participants. First made available on March 15th 2023, it seeks 600 volunteers from 49 medical sites." - Anonymous Online Contributor

Unverified Answer

Is there an opportunity to partake in this clinical study?

"This clinical trial is seeking 600 children aged between 4 and 7 who have been diagnosed with a peanut allergy. Participants must present an IgE level of more than 0.7 kUA/L, demonstrate a positive response to the skin prick test (SPT) with 6mm or greater in wheal diameter, and elicit an elicited dose (ED) of 100mg peanut protein during screening double blind placebo control food challenges (DBPCFC)." - Anonymous Online Contributor

Unverified Answer

Is there an opportunity for more individuals to join this trial?

"Data on clinicaltrials.gov verifies that this research endeavour is actively seeking out participants - the initial posting was made on March 15th 2023 and a recent update took place one day prior." - Anonymous Online Contributor

Unverified Answer

How many different sites are offering this clinical trial?

"Currently, this trial is operational at 49 sites spanning from Tucson to Los Angeles. To reduce travel-related issues, it's advantageous for prospective participants to pick a nearby location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.